LuxaPrint Ortho Flex 385
(Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer trays (in case of indirect bonding of brackets) using 3D printing. For DLP/ STL printers at a…
(Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer trays (in case of indirect bonding of brackets) using 3D printing. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Shade: Transparent, Content: 1 Bottle @ 500 g
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Yinchili Medical Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 3 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Wuxi EA Medical Instruments Technologies Limited | Wuxi | Jiangsu | Repacker / relabeller | 6 |
| Shenzhen Yongchanghe Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Xiamen Antinsky Industry Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
| Shanghai Smartee Denti-Technology Co., Ltd. | Shanghai | Shanghai | Exporter | 5 |
Record
| Listed by | DMG Digital Enterprises SE, Germany |
|---|---|
| FDA product code | QJJ |
| Device type | Indirect Bonding Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 15 to 25 °C; Special storage condition: Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately afte; Storage environment temperature 59 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 171253 | In distribution | |
| 171250 | In distribution | |
| 171252 | In distribution | |
| 171251 | In distribution | |
| 171284 | In distribution | |
| 171275 | In distribution | |
| 171281 | In distribution | |
| 171273 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MED610 | Stratasys Ltd | 5 |
| LuxaPrint Ortho Flex NX | DMG Digital Enterprises SE | 5 |
| KeyPrint | Keystone Industries | 2 |
| IDB 2 | Sprintray Inc. | 1 |
| ClearCorrect System Engager Template | Clearcorrect Operating, LLC | 1 |
| DentaIBT | Asiga | 1 |
| ClearCorrect System | Clearcorrect Operating, LLC | 1 |
| Custom Orthodontic Solution | Klowen Braces | 1 |
| Attachment Template | Align Technology, Inc. | 1 |
| Indirect Bond-EZ_HardSoft | Five Star Orthodontic Laboratory & Supply, Inc. | 1 |
| IDB 3 | Sprintray Inc. | 1 |
| Indirect Bond | Five Star Orthodontic Laboratory & Supply, Inc. | 1 |
Showing 12 of 18. All products under Indirect Bonding Tray
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.